The present invention pertains generally to medical methods, devices, and systems, and more particularly to methods, devices, and systems for a) revascularization and/or b) performing medical procedures at vascular or non-vascular intracorporeal locations within a mammalian body.
A. Background Relating to Revascularization Procedures
In modern medical practice, it is often desirable to bypass segments of artery which have become obstructed, diseased or injured. The typical surgical procedures used for bypassing of obstructed, diseased or injured segments of blood vessel require open surgical exposure of the artery, and the attachment (e.g., suturing) of a tubular graft (e.g., homograft, xenograft, allograft, prosthetic or bioprosthetic graft) to the affected artery such that one end of the graft is connected upstream of the obstructed, diseased or injured segment, and the other end of the graft is connected to the artery downstream thereof. In this manner, arterial blood is channeled through the bypass graft, thereby restoring blood flow distal to the obstructed, diseased or injured segment of artery, and preventing tissue ischemia, infarction, and other sequelae which may result from impaired blood flow through the affected artery.
Although surgical bypass grafting of arteries has been performed at various locations within the body, it is most typical for such arterial bypass procedures to be performed for the treatment of either i) coronary artery disease or ii) peripheral vascular disease affecting the lower extremities.
i. Coronary Artery Disease
Coronary artery disease continues to be one of the leading causes of morbidity and mortality, throughout the world. The typical etiology of coronary artery disease is characterized by the build-up of atherosclerotic plaque within the coronary arteries. Such deposits of atherosclerotic plaque tend to fully or partially block the flow of blood through the affected coronary arteries, and if untreated can result in myocardial ischemia, infarction and death.
For many years, the traditional surgical treatment of coronary artery disease has been coronary artery bypass surgery wherein the patient is generally anesthetized, placed on cardiopulmonary bypass and the patient""s heart is temporarily stopped. A thoracotomy (e.g., a median sternotomy) is performed and the obstructed coronary blood vessels are exposed by surgical dissection. One or more segments of the patient""s saphenous vein or internal mammary artery is/are harvested for use as bypass graft(s). The harvested segment(s) of vein or artery is/are then anastomosed to the obstructed coronary artery(ies) to form bypass conduit(s) around the arterial obstruction(s). Such traditional coronary artery bypass surgery is expensive, extremely invasive, and is associated with significant operative and postoperative complications.
One alternative to traditional coronary artery bypass surgery is balloon angioplasty. In balloon angioplasty, a flexible guide catheter is percutaneously inserted into a peripheral artery (e.g., the femoral artery) and is transluminally advanced through the vasculature until the distal tip of the catheter is within the ostium of an obstructed coronary artery. Thereafter, a balloon catheter is passed through the guide catheter and into the obstructive lesion. The balloon of the balloon catheter is inflated one or more times to dilate the coronary artery in the region of the obstructive lesion. These balloon angioplasty procedures tend to be less expensive and less traumatic than traditional coronary artery bypass surgery. However, balloon angioplasty procedures of this type may be associated with a significant incidence of restenosis at the angioplasty site. The cause and mechanism of such restenosis continues to be the subject of ongoing study. However, such restenosis has generally been attributed to either a) an increase in the mass of the artery wall (e.g., neointima formation), b) a thickening of the artery wall without substantial change in it""s mass (e.g., vascular remodeling) and/or c) radial contraction of the balloon-dilated artery wall upon healing of cracks and fissures that have been created by the balloon dilation process.
Another alternative to traditional coronary artery bypass surgery is intraluminal removal (e.g., atherectomy) or ablation (e.g., ultrasound, laser) of the obstructive matter within the coronary artery. These intraluminal removal or ablation procedures are performed by passing a catheter-mounted removal or ablation apparatus through the vasculature to the site of the coronary obstruction. The catheter-mounted removal or ablation apparatus is then utilized to cut, shave, sonicate, pulverize, or vaporize or otherwise ablate the obstructive matter from the lumen of the coronary artery. These procedures must be performed with caution to avoid perforation or damage to the artery wall, as such perforation or damage can result in hemorrhage or excessive scaring and subsequent reocclusion of the artery lumen. Furthermore, these ablative procedures may, in some cases at least, be confounded by the need to meticulously contain and remove dislodged or severed fragments of the obstructive matter, in order to prevent such fragments of obstructive matter from escaping into the patient""s circulatory system. Examples of atherectomy catheters and other catheter-mounted ablative apparatus are described in U.S. Pat. Nos. 3,433,226 (Boyd), 3,823,717 (Pohlman, et al.), 4,808,153 (Parisi), 4,936,281 (Stasz), 3,565,062 (Kuris), 4,924,863 (Sterzer), 4B70,953 (Don Michael, et al.), 5,069,664 (Suess, et al.), 4,920,954 (Alliger, et al.) and 5,100,423 (Fearnot), as well as foreign patents/patent publications EP0347098A2-(Shiber), WO87-05739 (Cooper), WO89-06515 (Bernstein, et al.), WO90-0130 (Sonic Needle Corp.), EP316789 (Don Michael, et al.), DE 3,821,836 (Schubert), DE2438648 (Pohlman), and EP 0443256A1 (Baruch).
Other alternatives to traditional coronary artery bypass surgery have included minimally invasive endoscopic procedures which may, ostensibly at least, be performed through small (e.g., 1-3 cm) incisions formed in the patient""s chest wall, by insertion of a thoracoscope and associated operative instruments through such incisions. One such minimally invasive coronary bypass procedure is described in U.S. Pat. No. 5,452,733 (Sterman et al.). If perfected, these minimally invasive coronary artery bypass procedures may lessen the discomfort and length of recovery time experienced by patients who undergo such minimally invasive procedures vis a vis those who undergo traditional coronary artery bypass surgery. However, endoscopic surgical procedures of this type typically require a great deal of operator skill and training. Furthermore, as with traditional coronary artery bypass surgery, these thoracoscopic procedures are typically performed under general anesthesia, and typically require that one or more chest tubes be left in place during the postoperative period to drain any blood which leaks from the graft anastomoses and to reduce the pneumothorax which has been created by the formation of full-thickness incision(s) in the chest wall. Moreover, some of these thoracoscopic coronary artery bypass procedures require that the patient be placed on cardiopulmonary bypass, and that the patient""s heart be temporarily stopped. Others of these thoracoscopic procedures purport to be useable without placing the patient on cardiopulmonary bypass, and without stopping the heart. However, those thoracoscopic procedures which are purported to be useable without cardiopulmonary bypass and heart stoppage are relatively complex to perform and typically require temporary clamping or ligating of the coronary artery which is to be bypassed. Accordingly, even those thoracoscopic procedures which may be useable without cardiopulmonary bypass/heart stoppage are prone to unique and significant risks and difficulties due to the complexities of the procedure and the need for temporary clamping or closing off the coronary artery(s) being bypassed. Thus, many of the drawbacks associated with traditional coronary artery bypass surgery, as well as some other potential drawbacks, may be associated with these minimally invasive thoracoscopic procedures.
Another previously described procedure which does not actually bypass coronary artery obstructions but which nonetheless may be useable to improve blood flow to ischemic regions of the myocardium, is a procedure known as transmyocardial revascularization (TMR). In the TMR procedure a tissue-penetrable probe, such as a laser probe, is utilized to form numerous full-thickness penetrations through the ischemic myocardial wall, and into the chamber of the left ventricle. Oxygenated blood from the left ventricle then flows outwardly through such penetration tracts, so as to perfuse the ischemic myocardium. Examples of such transmyocardial revascularization procedures are described in U.S. Pat. Nos. 5,554,152 (Aita et al.), 5,380,316 (Aita et al.), and 5,125,926 (Linhares et al.)
One modification of the TMR procedure requires the formation of a valved and/or internally stented transmyocardial passageway (e.g., an interstitial tunnel formed in the muscular wall of the heart) from the left ventricle of the heart to an obstructed coronary artery, downstream of the obstruction. Such modified TMR procedures are described in U.S. Pat. Nos. 5,287,861 (Wilk), 5,409,019 (Wilk), and 5,429,114 (Wilk).
ii. Peripheral Vascular Disease
Peripheral vascular disease commonly results from the build up of atherosclerotic plaque and/or thrombotic matter within peripheral arteries. In many cases, when arteries of the lower extremities have become obstructed by peripheral vascular disease, a phenomenon known as intermittent claudication results. Intermittent claudication is characterized by the occurrence of pain and progressive weakness in the legs during exertion (i.e., walking or running).
The typical surgical approach to the treatment of peripheral vascular disease, especially in patients who exhibit symptoms of intermittent claudication, is to surgically expose the affected artery and to anastomose a tubular bypass graft (e.g., a tube formed of woven polyester or expanded polytetrafluoroethylene (ePTFE)) to the affected artery such that one end of the graft is attached upstream of the obstruction, and the other end of the graft is attached downstream of the obstruction. In this manner, arterial blood will flow through the tubular bypass graft and around the arterial obstruction, thereby restoring blood flow to the portion of the artery downstream of the obstruction.
One alternative to traditional arterial bypass graft surgery for the treatment of peripheral vascular disease of the lower extremities, is a procedure known as in situ vein bypass. These in situ vein bypass procedures are typically carried out by forming at least two (2) open incisions in the leg, to expose the affected artery at sites upstream and downstream of the obstruction. A peripheral vein, which extends through the leg generally parallel to the affected artery, is then prepared by inserting an instrument into the vein to lyse or disrupt the venous valves located within the vein. Thereafter, any side branches which extend from the vein are cut, ligated or blocked by embolization. The prepared vein is then transected at locations above and below the arterial obstruction, and the transected ends of the vein are placed in contact with, and sutured directly to, the artery at sites upstream and downstream of the obstruction. In this manner, arterial blood flow becomes channeled through the prepared segment of vein, such that the prepared segment of vein will act as bypass conduit around the arterial obstruction. Examples of current in situ vein bypass procedures are described in White, R. A. and Fogarty, T. J., Peripheral Endovascular Interventions, Pgs., 166-169, Mosby and Co. (1996).
iii. Trauma and Other Diseases Which May
Impair Flow Through Arteries
Various arteries of the body may become damaged by trauma (e.g., lacerations, crushing injury, blunt abdominal trauma) or may become invaded or compressed by extra-vascular disease processes (e.g., proliferation and ingrowth of an adjacent tumor). The typical surgical approach to treatment of arteries affected by such trauma or disease is to surgically expose and dissect the affected segment of artery, and to thereafter a) resect and reconnect or b) bypass the affected segment of artery, to restore arterial blood flow through or around the affected segment of the artery. In many such cases, the segment of artery affected by the injury or disease may be so large as to preclude simple resection, removal of the affected segment, and end-to-end anastomosis of the adjacent cut ends of the artery. Accordingly, in such instances where resection and end-to-end anastomosis is not an available option, it may be desirable to attach a tubular bypass graft (e.g., a tubular graft formed of woven polyester, or ePTFE) to the affected artery, to bypass the affected segment of the artery.
Although a number of the above-described surgical procedures represent relatively recent advancements whereby the invasiveness and risk associated with traditional surgical approaches have been mitigated, there remains a need in the art for the development of new, safe, and reliable minimally invasive and/or transluminal procedures for bypassing segments of arteries which have become obstructed, injured or affected by disease.
B. Background Relating to Other Extravascular Surgical/Interventional Procedures
Many types of surgical and interventional procedures have previously been formed in organs, tissues or body cavities of the body. Traditionally, access to such organs, tissues or body cavities is attained through the formation of one or more open surgical incisions in the body, whereby the affected organs, tissues or body cavities are surgically exposed.
In recent years, substantial efforts have been undertaken to develop xe2x80x9cminimally invasivexe2x80x9d surgical techniques whereby one or more endoscopes are utilized to view the affected organ, tissue or body cavity, and wherein operative instruments or other devices are inserted into the body to accomplish the desired surgical or interventional procedure through relatively small, xe2x80x9cminimal accessxe2x80x9d (e.g., less than 3 cm) incisions.
Although the advent of these endoscopic xe2x80x9cminimal accessxe2x80x9d surgical procedures may have advantageous over traditional open surgical techniques insofar as they may minimize the size of the surgical incision, and accordingly, may lead to less post-operative discomfort, such endoscopic procedures are often limited to procedures within accessible body lumens or cavities which may be filled with clear liquid or insufflated with a gas to provide an open area within which to place the operative endoscope(s) and instrument(s).
In view of the limitations associated with the even the most modern xe2x80x9cminimal accessxe2x80x9d surgical and interventional procedures, there remains a need in the art for the development of new methods and apparatus for accessing tumors, organs, tissues and other extravascular locations within the body, to permit the performance of surgical and/or interventional procedures without the need for forming any open surgical incisions in the body.
In general, the present invention provides methods for using the vascular system of a mammalian body as a conduit for performing various types of medical procedures. Due to the wide distribution of vessel conduits throughout the body, the vascular system provides a highway through which devices can be navigated to reach selected treatment sites which may be otherwise accessible only through a direct incision. The specific methods of the present invention include a) revascularization methods, and b) methods for performing various types of medical procedures at other intracorporeal locations within the body.
The revascularization methods of the present invention generally comprise the formation of one or more extravascular passageways between blood vessels, different locations on the same blood vessel, or a blood vessel and another blood-containing anatomical structure (e.g., chamber of the heart), such that blood will flow through such passageway(s). In many applications of the invention, it will be desirable for oxygenated blood (i.e., blood which has a pO2 greater than 50) to be carried through the extravascular passageway(s) for the purpose of providing or enhancing perfusion of tissues. The extravascular passageways formed in accordance with the revascularization methods of the present invention may be formed by a percutaneous, transluminal approach which avoids the formation of open surgical incisions in the mammalian body. These revascularization methods of the present invention may be useable in peripheral blood vessels and/or in coronary blood vessels.
In accordance with the revascularization methods of the present invention, there are provided procedures for providing arterial blood flow to a tissue which has been deprived of blood due to the presence of an obstruction, injury or disease within a segment of an artery. The method generally comprises the step of forming a first extravascular passageway between an anatomical conduit which contains arterial blood (e.g., an artery or chamber of the left heart), and a blood vessel which will perfuse the blood-deprived tissue, such that arterial blood will pass through the extravascular blood flow passageway and into the blood vessel, to theseby perfuse the blood-deprived tissue through the blood vessel. In some applications of this method, the first blood flow passageway will be formed between an artery and an adjacent vein, such that blood will flow from the artery into the adjacent vein and will. subsequently pass through the vein in the retrograde direction so as to back-perfuse tissue through the venous vasculature. Alternatively, a second blood flow passageway may be formed between the vein and the artery wherein the obstruction, injury or disease is located, such that arterial blood which has entered the vein will reenter the artery, downstream of the obstruction, injury or disease-affected segment thereof, thereby perfusing the blood-deprived tissue through the endogenous artery wherein the obstruction, injury or disease-affected segment is located.
The methods of the present inventions for performing medical procedure(s) at vascular or non-vascular target site(s) within the body. broadly comprise the step of forming at least one extravascular passageway from a blood vessel to another intracorporeal location (eg., blood vessel, organ, body cavity, tumor, etc.) and subsequently passing a substance or apparatus through the extravascular/passageway to perform the desired medical procedure at the selected intracorporeal location.
Further in accordance with the invention, there is provided a device which is insertable into a blood vessel and useable to form an extravascular passageway which extends from the blood vessel within which the catheter device is inserted to a target location the target location may be a) another blood vessel, b) another blood containing anatomical structure (e.g., chamber of the heart), c) another location on the same blood vessel, or d) an extravascular location (e.g., organ, tumor, body cavity, etc.)) The extravascular passageways formed by this catheter device may be used for performance of the methods of the revascularization and/or medical procedure present invention, as summarized hereabove. This passageway-forming catheter device may comprise an elongate, flexible catheter body having a tissue penetrating element (e.g., a member, device or flow of energy) which is passable from the catheter body, to form a passageway through the wall of the blood vessel in which the catheter is positioned, and through any other tissue located between the blood vessel and the target location (e.g., other blood vessel, anatomical structure, extravascular location, or other location on the same blood vessel) to which the passageway is desired to extend. The tissue-penetrating element may comprise a suitable type of tissue-penetrating member, device or flow of energy, including but not necessarily limited to a hollow and/or solid needle, trocar-tipped needle (with or without a surrounding pliable sheath), laser beam, laser-emitting member, electrocautery probe, hot-tipped probe, rotating tissue penetrating apparatus, or ultrasonic ablation probe. Optionally, the catheter device may be equipped with suction lumen, inflatable balloon(s) or other structural attributes or apparatus useable to facilitate or assist the passage of the tissue-penetrating element (e.g., member, apparatus, flow of energy) from the blood vessel to the selected target location. Also, optionally, the tissue-penetrating element of the catheter device may incorporate a guide wire lumen or other means for passing a guide wire through the extravascular passageway formed by the tissue-penetrating element.
Further in accordance with the invention, the passageway-forming catheter device of the foregoing character may be combined with one or more apparatus for orienting the tissue-penetrating element to insure that the extravascular passageway is formed at its intended location. Such orienting apparatus may be mounted, upon, or incorporated into the passageway-forming catheter, or, such orienting apparatus may be formed separately of the passageway-creating as catheter and used in conjunction with the catheter, from any suitable intracorporeal and/or extracorporeal location. The orienting apparatus my comprise various types of active and/or passive apparatus including, but not limited to, extracorporeal or intracorporeal ultrasound apparatus, extracorporeal or intracorporeal Doppler apparatus, intracorporeal or extracorporeal radiographic apparatus, magnetic resonance imaging apparatus, tomography apparatus, induction coils, electromagnetic devices, and various catheter-borne markers which are identifiable by radiographic, sonic, ultrasonic, photographic, MRI, or other means.
Still further in accordance with the invention, there are provided passageway-modifying devices for debulking, lining, stenting, longitudinally compressing and/or otherwise modifying the extravascular passageway(s) which are formed by the present invention.
Further objects and advantages of the present invention will become apparent to those skilled in the art upon reading the detailed description of preferred embodiments set forth herebelow, wherein certain presently-preferred embodiments and examples of the invention are set forth in detail.